The method of claim 14, wherein the volatile organic solvent is acidified. Non- limiting examples of acid include HC1, citric acid, acetic acid or glutamic acid or other inorganic acids or organic acids known in the art. The volatile organic solvent may be used to facilitate binding of the lipophilic agents to the polymeric solvent via electrostatic interactions. The findings of McDonald and coworkers suggest that inter- individual differences in metabolic drug handling are of importance for developing VOD, such that, in addition to Bu, Cy conceivably contributes to the overall risk of VOD McDonald et at.
To be absorbed in the human body, a compound has to be soluble in both water and fats lipids. For example, the amphiphilic liquid polymeric solvent may be a PEG solvent such as PEG, - and the like. Optionally, such non-aqueous composition may be further diluted with an aqueous solvent while the lipophilic agent could remain stable and solubilized. The use according to claim 32 wherein the antifungal azole is itraconazole or posaconazole. However, in addition to Bu, Cy is clearly hepatotoxic.
For example, there may be provided a non-aqueous composition that comprises a lipophilic pharmaceutical agent, and an amphiphilic polymeric solvent such as PEG but essentially free of organic solvents and non-solubilized particles. The non-aqueous, homogeneous solution of claim 9, wherein the protonating agent is an acid, alcohol or acidified alcohol. In particular, the aqueous infusion fluid may be 0. The method of claim 19, wherein said evaporation is facilitated by application of vacuum.
A particular example may be PEG The PEG used herein may exclude any PEG that is in a solid state at a selected temperature such as room termperature, body temperature or a temperature of at least, about or at most 5, 10, 15, 20, 21, 22, 23, 24, 25, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 45, 50, 55, 60, 65, 70, 75, 80 C, or any range or value derivable therein, such as PEG with a high molecular weight average molecular weight of at least or more than, 10, dalton or any intermediate ranges.
In other aspects, the subject has a fungal, yeast or mold disease and the lipophilic pharmaceutical agent is an azole agent. Abrégé français L'invention peut concerner des compositions d'agents pharmaceutiques lipophiles présentant une solubilité et une stabilité améliorées. Les textes des Revendications et de l'Abrégé sont affichés L'invention peut concerner des compositions d'agents pharmaceutiques lipophiles présentant une solubilité et une stabilité améliorées.
The non-aqueous, homogeneous solution of claim 11, wherein the solution has a pH of from 1 to 6. Even though the overall incidence of serious hepatic toxicity is decreased when comparing the oral and IV Bu-Cy2 regimens Kashyap et at. Interestingly, the pattern of liver toxicity appears somewhat different than what was previously experienced with oral Bu; commonly there is a silent hyperbilirubinemia in about a third of the patients, having its onset within about a week of IV Bu delivery, and if clinical VOD occurs, it now commonly happens at a later time than what was previously encountered.
The non-aqueous, homogeneous solution of any one of claims 1 to 8, wherein the solution further comprises a protonating agent. To facilitate the interaction between the reactive groups in the lipophilic agents and amphiphilic solvents, the volatile organic solvent or the desired aqueous diluent may be acidified. The solution composition may optionally further comprise an aqueous diluent such as an aqueous infusion fluid, which may be used to facilitate the subsequent systemic administration to a mammal, preferably a human or a large domestic animal.
Les taxes sur les brevets sont ajustées au 1er janvier de chaque année. The non-aqueous, homogeneous solution of claim 1, wherein the lipophilic pharmaceutical agent is the anticancer agent busulfan, or wherein the antifungal azole is itraconazole Itra or posaconazole Posa. Il peut s'agir par exemple d'une composition non aqueuse comprenant un agent pharmaceutique lipophile, ainsi qu'un solvant polymère amphiphile tel que PEG, pour l'essentiel exempt de solvants organiques et de particules zoloft 25 mg ibs solubilisées.
The toxicity from virtually any myeloablative preparative regimen has been associated with the development of VOD Jones et al.
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